AB1000 ACHIEVEMENT OF INCREASINGLY STRINGENT CLINICAL RESPONSE CRITERIA AND LOWER LEVELS OF DISEASE ACTIVITY WAS ASSOCIATED WITH GREATER IMPROVEMENTS IN PHYSICAL FUNCTION AND HRQOL IN PATIENTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS: 52-WEEK RESULTS FROM TWO PHASE 3 STUDIES ON BIMEKIZUMAB
Authors: M. Magrey, A. Deodhar, P. J. Mease, V. Navarro-Compán, S. Ramiro, M. Rudwaleit, C. De la Loge, C. Fleurinck, V. Taieb, M. Morup, M. Oortgiesen, J. Kay
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Patients with axial spondyloarthritis (axSpA) can experience a significant burden due to the pain, fatigue and impaired physical function resulting from the disease.<sup>[1]</sup> <h3>Objectives</h3> To assess how achievement of increasingly stringent clinical response criteria and lower disease activity levels translates into improvements in physical function, sleep and health-related quality of life (HRQoL) in patients with axSpA. <h3>Methods</h3> This post hoc analysis reports results from the phase 3 studies, BE MOBILE 1 (NCT03928704; non-radiographic axSpA [nr-axSpA]) and BE MOBILE 2 (NCT03928743; radiographic axSpA [r-axSpA], i.e., ankylosing spondylitis<sup>[2]</sup>) at Week (Wk) 52. In BE MOBILE 1, patients met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA and had elevated C-reactive protein and/or MRI sacroiliitis. In BE MOBILE 2, patients had radiographic sacroiliitis, fulfilling modified New York criteria. All patients who completed Wk 52 and reached specified clinical response criteria (<b>ASAS</b>: ASAS20 not reached [&lt;ASAS20], ASAS20 reached but not ASAS40 [ASAS20–&lt;ASAS40], ASAS40 reached [ASAS40]; <b>ASAS-PR</b>: Yes, No; <b>BASDAI50</b>: Yes, No), <b>ASDAS</b> (≥2.1, ≥1.3–&lt;2.1, &lt;1.3) or <b>ASDAS responses</b> (major improvement [change from baseline ≥2.0], clinically important improvement [change ≥1.1 but &lt;2.0], non-response [change &lt;1.1]) were pooled regardless of their original treatment arm (placebo then BKZ from Wk 16 or continuous BKZ 160 mg Q4W; all subcutaneous BKZ), by study. Associations between achievement of these clinical responses and improvements in patient-reported measures of physical function (<b>BASFI</b>; <b>SF-36 PCS</b>), sleep (<b>MOS Sleep-R Index;</b> 12 item measure, higher scores reflect more of the attribute implied by the scale) and HRQoL (<b>ASQoL</b>) were assessed. Observed case data are reported. <h3>Results</h3> Most patients completed Wk 52 (nr-axSpA: 220/254 [86.6%]; r-axSpA: 298/332 [89.8%]). Baseline demographics and disease characteristics were generally similar between nr-axSpA and r-axSpA patients, aside from gender, HLA-B27 status, symptom duration and time since first diagnosis, indicating similar burden of symptom severity, reduced physical function and HRQoL. Across studies, patients achieving increasingly stringent ASAS responses presented sequentially greater mean (95% confidence interval) improvements from baseline in BASFI (<b>Figure 1</b>) and SF-36 PCS score (nr-axSpA: &lt;ASAS20: 5.1 [2.5, 7.7], ASAS20–&lt;ASAS40: 9.5 [7.1, 11.8], ASAS40: 14.6 [13.1, 16.2]; r-axSpA: 5.9 [4.1, 7.7], 8.4 [6.6, 10.2], 14.6 [13.3, 15.9]). Achievement of higher ASAS response was also associated with sequentially greater mean improvements from baseline in MOS Sleep-R index scores (nr-axSpA: &lt;ASAS20: 3.6 [1.3, 6.0], ASAS20–&lt;ASAS40: 3.9 [1.6, 6.2], ASAS40: 9.0 [7.4, 10.6]; r-axSpA: 0.7 [−1.2, 2.6], 4.9 [2.5, 7.3], 8.2 [7.2, 9.3]) and ASQoL (nr-axSpA: &lt;ASAS20: −2.2 [−3.7, −0.7], ASAS20–&lt;ASAS40: −4.3 [−5.5, −3.2], ASAS40: −7.2 [−7.9, −6.5]; r-axSpA: −2.0 [−3.0, −1.1], −4.3 [−5.1, −3.4], −6.9 [−7.5, −6.3]). Similar sequential improvements from baseline in BASFI, SF-36 PCS, MOS-Sleep R index and ASQoL were observed with achievement of ASAS-PR, BASDAI50, and ASDAS-related outcome measures. Improvements in BASFI, SF-36 PCS, MOS Sleep-R index and ASQoL were of similar amplitude between nr-axSpA and r-axSpA patients. <h3>Conclusion</h3> Patients with nr-axSpA and r-axSpA who achieved increasingly stringent clinical response criteria and lower levels of disease activity at Wk 52 reported greater improvements in physical function, sleep function and HRQoL. Similar amplitudes of improvement for each response level were observed across the axSpA disease spectrum. <h3>Reference</h3> [1]Yi E. Rheumatol Ther 2020;7(1):65-87; <b>2.</b> Boel A. Ann Rheum Dis. 2019;78:1545–9. <h3>Acknowledgements</h3> This study was funded by UCB Pharma. Medical writing support was provided by Costello Medical, funded by UCB Pharma. <h3>Disclosure of Interests</h3> Marina Magrey Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and UCB Pharma, Atul Deodhar Speakers bureau: Janssen, Novartis and Pfizer, Consultant of: AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma, Philip J Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, MoonLake, Novartis, Pfizer, Sun Pharma and UCB Pharma, Grant/research support from: AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Victoria Navarro-Compán Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Galapagos, Moonlake, MSD, Novartis, Pfizer and UCB Pharma, Grant/research support from: AbbVie and Novartis, Sofia Ramiro Consultant of: AbbVie, Eli Lilly, Novartis, Pfizer, Sanofi and UCB Pharma, Grant/research support from: AbbVie, Galapagos, MSD, Novartis, Pfizer, UCB Pharma, Martin Rudwaleit Speakers bureau: AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Paid instructor for: Janssen, Novartis and UCB Pharma, Consultant of: AbbVie, Eli Lilly, Novartis and UCB Pharma, Christine de la Loge Consultant of: UCB Pharma, Carmen Fleurinck Employee of: UCB Pharma, Vanessa Taieb Employee of: UCB Pharma, Michael Morup Employee of: UCB Pharma, Marga Oortgiesen Shareholder of: UCB Pharma, Employee of: UCB Pharma, Jonathan Kay Consultant of: Alvotech Swiss AG, Boehringer Ingelheim GmbH, Organon, Ridgeline Discovery, Samsung Bioepis, Sandoz Inc., Scipher Medicine and UCB Pharma, Grant/research support from: Gilead and Novartis paid to institution.